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NCT05701722
Effect of Flourish HEC Vaginal Care System on BV Recurrence and the Vaginal Microbiome
NA trial testing Flourish HEC Vaginal Care System in Bacterial Vaginosis in 7 participants. Completed in 15 February 2024.
15 February 2024
Quick facts
| Lead sponsor | Vaginal Biome Science |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 7 |
| Start date | 29 March 2023 |
| Primary completion | 15 February 2024 |
| Estimated completion | 15 February 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Flourish HEC Vaginal Care System
Conditions studied
- Bacterial Vaginosis — all drugs for Bacterial Vaginosis →
Sponsor
Vaginal Biome Science
Who can join
Adults 18 to 52, female only, with Bacterial Vaginosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to learn about the vaginal microbiome in premenopausal women with recurrent bacterial vaginosis (BV). The main questions it aims to answer are: * Does using a specific vaginal care system reduce recurrence of BV? * How does using this vaginal care system change the vaginal microbiome and pH over time? Participants will: * Have their vaginal microbiome and pH tested in several ways at three timepoints: the start of the study, 12 weeks later, and 24 weeks after the start of the study * Answer questionnaires about vulvovaginal symptoms at each of these three timepoints * Use a specific vaginal care system at home for 24 weeks, consisting of an intimate wash, a vaginal moisturizing gel, and a vaginal probiotic suppository, if assigned to the intervention group Researchers will compare the group using the vaginal care system with a control group that does not use the system to see if using the system reduces risk of BV recurrence or changes the vaginal microbiome, pH, or symptoms.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05701722
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bacterial Vaginosis
Currently open trials in the same condition.
- NCT07234786 — Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections · NA · recruiting
- NCT06458543 — Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age · Phase 4 · recruiting
- NCT06263465 — Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis · NA · recruiting
- NCT05753813 — Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome · EARLY_PHASE1 · recruiting
- NCT06616168 — Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens · Phase 1 · active not recruiting
Other Vaginal Biome Science trials
Trials by the same sponsor.
- NCT06472765 — Vaginal Ecosystem and Network in the United States Study · enrolling by invitation
- NCT05573334 — Vaginal Care System for Menopausal Women With Urinary Tract Infections · NA · completed
- NCT05665569 — Effects of Flourish HEC Vaginal Care System on Birth-Related Pelvic Floor Disorders · NA · terminated
- NCT05478746 — Effects of Flourish HEC on Localized Provoked Vulvodynia · NA · completed
- NCT05397782 — Effects of Flourish on Recurrent Urinary Tract Infection · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05701722 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vaginal Biome Science
- Last refreshed: 7 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05701722.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing